Location: New York, NY
Cap-Exempt H-1B Position — No lottery required
- Job Type: Officer of Administration - Bargaining Unit: - Regular/Temporary: Regular - End Date if Temporary: - Hours Per Week: 35 - Standard Work Schedule: Mon - Fri (9am - 5pm) - Building: Columbia University Medical Center - Salary Range: $80,000 - $100,000 *The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.* Position Summary The Regulatory & Compliance Manager will report to the Assistant Director of Research Quality and Compliance. This role will be responsible for overseeing regulatory operations for clinical research studies within the Departments of Surgery, Otolaryngology, Neurosurgery, and Urology. The Regulatory Manager will ensure adherence to federal, state, institutional, and sponsor regulations governing human subjects research, including FDA-regulated IND/IDE studies and high-risk interventional trials. This role will supervise the Regulatory coordinators and Technicians and provide operational leadership in regulatory start-up, maintenance, continuing review, and close-out activities. The Regulatory Manager will serve as a subject matter expert in regulatory compliance and provide guidance to investigators and research staff to ensure audit readiness and regulatory integrity across the department. Responsibilities **Regulatory Oversight & Compliance Management:** - Oversee regulatory submissions and lifecycle management for IRB, FDA (IND/IDE), sponsor, and institutional requirements. - Ensure timely preparation and submission of initial applications, amendments, continuing reviews, safety reports, reportable events, and study closures. - Maintain oversight of regulatory binders and electronic regulatory systems to ensure completeness, accu